FDA 510(k)

Cholestech LDX ™ System

Numéro K : K223179 · 2023-09-20

Date de décision2023-09-20

Code produitCGA

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

Cholestech LDX ™ System is the device name listed in this FDA 510(k) record. The listed applicant is Alere San Diego, Inc.. It received FDA 510(k) clearance on 2023-09-20 under 510(k) number K223179. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Cholestech LDX ™ System?

Cholestech LDX ™ System is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Alere San Diego, Inc.. The 510(k) number is K223179.

When did Cholestech LDX ™ System receive FDA 510(k) clearance?

Cholestech LDX ™ System received FDA 510(k) clearance on 2023-09-20, under 510(k) number K223179.

Who is the listed applicant for Cholestech LDX ™ System?

The FDA 510(k) record lists Alere San Diego, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cholestech LDX ™ System?

The FDA product code for Cholestech LDX ™ System is CGA.

Essais cliniques associés

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Dispositifs connexes (Code : CGA)

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Source officielle

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